Abstract
BackgroundSplit-thickness skin grafting (SSG) is an important modality for wound closure. However, the donor site becomes a second, often painful wound, which may take more time to heal than the graft site itself and holds the risk of infection and scarring. Epidermal grafting (EG) is an alternative method of autologous skin grafting that harvests only the epidermal layer of the skin by applying continuous negative pressure on the normal skin to raise blisters. This procedure has minimal donor site morbidity and is relatively pain-free, allowing autologous skin grafting in an outpatient setting. We plan to compare EG to SSG and to further investigate the cellular mechanism by which each technique achieves wound healing.Methods/designEPIGRAAFT is a multicentre, randomised, controlled trial that compares the efficacy and wound-healing mechanism of EG with SSG for wound healing. The primary outcome measures are the proportion of wounds healed in 6 weeks and the donor site healing time. The secondary outcome measures include the mean time for complete wound healing, pain score, patient satisfaction, health care utilisation, cost analysis, and incidence of adverse events.DiscussionThis study is expected to define the efficacy of EG and promote further understanding of the mechanism of wound healing by EG compared to SSG. The results of this study can be used to inform the current best practise for wound care.Trial registrationClinicaltrials.gov identifier, NCT02535481. Registered on 11 August 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1352-y) contains supplementary material, which is available to authorized users.
Highlights
Split-thickness skin grafting (SSG) is an important modality for wound closure
This study is expected to define the efficacy of Epidermal grafting (EG) and promote further understanding of the mechanism of wound healing by EG compared to SSG
Sample size Our pilot study revealed that both techniques offer the same healing rate at 6-weeks post-grafting; the donor site morbidity is present in 40 % of the patients with split-thickness skin graft while only 5 % is seen in patients with the epidermal graft
Summary
Wound care presents a significant financial and resource burden to the healthcare system, with about £5.0 billion spent annually in caring for patients with wounds in the United Kingdom alone. The skin biopsy from the wound edge will be used to study the migratory activity of the keratinocytes by determining the expression pattern of the Connexin proteins. It is known that the downregulation of Connexin protein at the edges of the wound correlates with increased keratinocytes migratory activity, resulting in accelerated wound healing [17]. This study is expected to define the efficacy of EG and further understand the mechanism of wound healing by EG compared to SSG. These results can be used to inform the current best practise for wound care.
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